FDA Final Guidance On BPH Device Studies Suggests Swift Patient Follow-Up

27 Dec 2021

• By Shawn M. Schmitt

A new guidance document from the US agency strongly urges makers of medical devices for treating benign prostatic hyperplasia (BPH) – a common form of age-related prostate enlargement – to quickly conduct post-treatment evaluations as part of investigational studies.

Doctor holds wooden blocks with the word 'BPH'. — • Source: Alamy

A new final guidance document from the US Food and Drug Administration strongly urges makers of medical devices for treating benign prostatic hyperplasia (BPH) – a common form of age-related prostate enlargement – to swiftly conduct post-treatment evaluations as part of investigational studies.

“We recommend the post-treatment evaluation schedule include multiple follow-up visits spanning the entire study duration, eg, two weeks (unless there...